2014 Next Generation Dx Summit Preview

By Clinical
Informatics News Staff

August 13, 2014 | Next
week, from August 18-21, the 2014 Next Generation Diagnostics Summit will
convene in Washington, DC. The annual summit, now in its sixth year, provides a
setting where industry leaders, regulators, hospital directors, medical
ethicists and others can discuss the rapidly evolving field of molecular
diagnostics and the clinical use of genetic testing.

This year’s event comes in the immediate wake of a major FDA
announcement, that the agency plans to begin regulating laboratory developed
tests in much the same way it does other in
vitro diagnostics. (Clinical
Informatics News recently ran
an explainer on the issues surrounding LDT regulation and the FDA’s
proposed timeline.) That proposal will be a major focus of conversation next
week, including in a dedicated session with guest speaker Jennifer Dickey from
the FDA’s Office of In Vitro
Diagnostics. Details of how the agency plans to implement regulations, and
which LDTs will be classified in higher risk groups requiring earlier action,
remain under consideration.

The summit will also have an increased focus on next
generation sequencing this year, as the past twelve months have marked the first
appearance of an FDA-approved next generation sequencer for clinical settings.
(See “MiSeqDx
Foreshadows Expanded Universe of Clinical Sequencing.”) NGS will be a
central feature of conference tracks including Companion Diagnostics, Predictive
Cancer Biomarkers, and Molecular Diagnostics for Infectious Disease, as well as
a newly introduced track on NGS-Based Assays in the Clinical Setting. Other
tracks appearing for the first time this year include Inherited Disease
Diagnostics, Cell-Free DNA, and Single-Cell Sequencing.

Here is a sampling of talks we’re looking forward to at this
year’s conference.

— The Editors

In Tuesday’s opening keynote, Jeff Boyd, chief of molecular pathology at Fox Chase Cancer Center
and executive director of the Cancer Genome Institute, will recount how his
program has adopted genomic technology in the diagnosis and treatment of
cancer. Tuesday, August 19, 8:40 am

In a simultaneous session, Pawan Jain, a senior regulator at the FDA, and an expert panel will
discuss how point-of-care diagnostic tests can be more quickly and effectively
deployed in low-resource areas where residents have limited access to clinical
services. Tuesday, August 19, 8:40 am

Jennifer Dickey,
of the Office of In Vitro Diagnostics
at the FDA, will join the summit for two presentations. First, she will address
the issue of NGS-based companion diagnostics, and suggest how such personalized
medicine applications might win FDA approval. Then, she will speak more broadly
about the agency’s approach to new NGS tests. Dickey will also participate in
an open Q&A with the audience. Wednesday,
August 20, 9:30 am and 11:10 am

In a joint panel, Elaine
Lyon, Andrea Ferreira-Gonzalez,
and Madhuri Hegde, all directors of university-affiliated
genetics laboratories, will share their experiences offering clinical NGS
testing, and their advice for securing reimbursement. Wednesday, August 20, 11:55 am

A Wednesday keynote featuring James Hicks of Cold Spring Harbor Laboratory, Sunney Xie of Harvard, and Maximilian
Diehn of Stanford will present new technologies and methods for single-cell
genomics, including applications in in
vitro fertilization and circulating tumor cells. Wednesday, August 20, 1:50 pm

Charles Chiu from
UC San Francisco will describe how NGS can be used to detect rare or novel
pathogens from clinical samples, including a case study. Wednesday, August 20, 2:30 pm

Justin Zook and Mark Salit of the National Institute of
Standards and Technology will present on the Genome in a Bottle Consortium’s
work producing highly curated human benchmark genomes for the validation of human
genotyping and variant discovery. Wednesday,
August 20, 5:45 pm

Živana Težak from
the FDA’s Center for Devices and Radiological Health will review the approval
of the MiSeqDx sequencer and four related tests, and consider the performance evaluation
process for other such instruments. Thursday,
August 21, 2:05 pm